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| |  ACR: Remicade (Infliximab) Plus Arava (Leflunomide) Safe and Effective in Patients with Rheumatoid Arthritis By Claire Sowerbutt Special to DG News SAN FRANCISCO, CA -- November 15, 2001 -- Remicade® (infliximab) in combination with Arava™ (leflunomide) has been shown to be safe and effective therapy for rheumatoid arthritis (RA) in patients unable to tolerate methotrexate (MTX). This finding comes from data collection on patients with RA from a variety of RA practices including single physicians, group RA practices and academic practices. The results were presented during the 65th Annual Meeting of the American College of Rheumatology. Clinical data so far suggest that leflunomide appears to be an alternative to MTX and sulfasalazine in patients with RA. Leflunomide is a new disease-modifying anti-rheumatic drug (DMARD) approved for the treatment of active RA to reduce signs and symptoms of the disease and to retard structural damage. Earlier data show that continuing leflunomide therapy for more than 12 months can result in clinically meaningful improvements in disease-specific measures of physical function. Infliximab is a chimeric, monoclonal antibody that binds with high affinity and specificity to tumour necrosis factor alpha (TNFa) and neutralizes its biological activity. It is well tolerated when administered either as monotherapy or with MTX. The study aimed to evaluate the safety and tolerability of the infliximab/leflunomide combination. Eighty patients were identified as having recently begun concomitant treatment with these agents. Generally, it appeared that patients were begun on leflunomide at 20 mg daily with the majority of them starting infliximab at 3 mg/kg every eight weeks. The majority of these patients also continued to use prednisone at doses ranging from 2.5 to 40 mg/day. Follow-up efficacy data were available on 33 patients and show that mean swollen and tender joint counts improved in 47 percent and 56 percent of patients, respectively. There was a mean functional class improvement of 20 percent. Furthermore, the mean prednisone dose was reduced by 33 percent (baseline, 7.6 mg/day; post-infliximab, 5.1 mg/day). Of the 48 patients receiving concomitant infliximab and leflunomide on whom safety data were available, there were no reports of serious adverse events. The most common side effects seen were nausea and vomiting (6 percent), anaphylactoid reaction (6 percent), headache (4 percent), myelodysplasia (unrelated) (4 percent), alopecia (2 percent), arthralgia/myalgia (2 percent), diarrhea (2 percent), and flu (2 percent). Investigators of this study are continuing to monitor these and other patients to better determine the clinical efficacy of infliximab and leflunomide combination therapy.
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